(85 days)
No
The description focuses on the mechanical function of a needle introducer and does not mention any computational or data-driven features indicative of AI/ML.
No.
The device facilitates the placement of a catheter and reduces needle stick risk; it does not directly treat a disease or condition.
No
The device is described as a "Safety Needle Introducer" used to "facilitate placement of a peripherally inserted intravenous catheter." Its function is to assist in the physical insertion of a catheter, not to diagnose a condition or disease.
No
The device description clearly states it is a "single patient, single use, stainless steel needle introducers with splittable sheaths," indicating it is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to facilitate the placement of a peripherally inserted intravenous catheter through the skin into a vein. This is a procedure performed directly on the patient's body.
- Device Description: The device is a needle introducer with a splittable sheath, designed for inserting a catheter into a vein. This is a physical tool used for a medical procedure.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze samples. This device is used in vivo (inside the body) to facilitate a medical procedure.
N/A
Intended Use / Indications for Use
The Safe-T-Peel® Safety Needle Introducer is used to facilitate placement of a peripherally inserted intravenous catheter, through the skin into a vein and when used according to the Instructions For Use (IFU) may reduce the risk of an accidental needle stick.
Product codes
FOZ, DYB
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5200 Intravascular catheter.
(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).
0
SEP 2 0 2002
Ko 22099
HDC Corporation's Safe-T-Peel® Safety Needle/Introducer 510(k) Summary
| Name of Device | Safe-T-Peel® Safety Needle/Introducer |
|---|---|
| Common or Usual Name | Safety Needle/Introducer |
| Classification Names | Catheter, Intravascular (Therapeutic, |
| Short-term less than 30 days) - 21 C.F.R. §880.5200 | |
| Product Codes | FOZ |
Submitter
HDC Corporation 628 Gibraltar Court Milpitas, CA 95035
Phone: (408) 942-7340 Facsimile: (408) 586-8680 Contact Person: Earl Smart Date Prepared: June 27, 2002June 26, 2002
Predicate Devices
| Becton Dickinson
Infusion Therapy
| Systems, Inc. | TFX Corporation | TFX Corporation |
|---|---|---|
| INTROSYTE | ||
| Autoguard | ||
| Shielded | ||
| Introducer | TFX Medical | |
| Introducer | ||
| Assembly | TFX Medical | |
| Safety Needle with | ||
| Introducer | ||
| (K013304) | (K993191) | (K000665) |
Intended Use
The Safe-T-Peel® Safety Needle Introducer is used to facilitate placement of a peripherally inserted intravenous catheter, through the skin into a vein and when used according to the Instructions For Use (IFU) may reduce the risk of an accidental needle stick.
1
Substantial Equivalence
All predicate devices presented for comparison with the Safe-T-Peel® Safety Needle/Introducer are single patient, single use, stainless steel needle introducers with splittable sheaths, intended to facilitate the placement of Peripherally Inserted Catheters (PICs). Additionally the Safe-T-Peel® Safetv Needle/Introducer contains a splittable plastic sheath identical to the one used in the TFX Medical Introducer Assembly (K993191).
The Safe-T-Peel® Safety Needle/Introducer is substantially equivalent to the previously cleared predicate device (K013304) with sharps injury prevention features because it has the same intended uses, similar principles of operation, similar technological characteristics and similar performance test results. The primary intended use is nearly identical to the primary intended use of Becton Dickinson's INTROSYTE Autoguard Shiclded Introducer (K013304), TFX Corporation's TFX Medical Introducer Assembly (K993191), and TFX Corporation's TFX Modical Safety Needle with Introducer (K000665). The secondary intended use (protection against needle stick injury) is nearly identical to that of both theK013304 and K000665 predicate devices. The sharps injury prevention mechanism is essentially identical to the mechanism used in Becton Dickinson's INTROSYTE Autoguard Shielded Introducer (K013304).
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 0 2002
HDC Corporation C/O Mr. Jonathan S. Kahan Hogan & Hartson, LLP Columbia Square 555 Thirteenth Street, NW Washington. D.C. 20004-1109
Re: K022099
Trade/Device Name: Safe-T-Peel® Safety Needle Introducer Regulation Number: 880.5200 and 870.1340 Regulation Name: Intravascular Catheter and Catheter Introducer Regulatory Class: II Product Code: FOZ and DYB Dated: June 27, 2002 Received: June 27, 2002
Dear Mr. Kahan:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into cither class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition. FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.
3
Page 2 – Mr. Kahan
You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594- 4618 . Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours,
Suren Ramo
Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
| 510(k) Number | K |
|---|---|
| Device Name | Safe-T-Peel Safety Needle Introducer |
Indications for Use The Safety T Reel Safety Needle Introducer is used to facilitateThe Safety-T-Peel Safety Needle Introducer is used to facilitate Indications for Use placement of a peripherally inserted intravenous catheter, through the skin into a vein and when used according to the Instructions For Use (IFU) may reduce the risk of an accidental needle stick.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-the-counter Use _________________________________________________________________________________________________________________________________________________________
Tallessa Vincenti
Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K022677